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FDA Approves Medications For Tardive Dyskinesia

September 28, 2017 | By Ken Duckworth, M.D.

Tardive dyskinesia (TD) is a movement disorder that occurs in some people who take first-generation antipsychotics (such as haloperidol, chlorpromazine), and to a lesser degree, second-generation antipsychotics (such as aripiprazole or paliperidone). TD results in repetitive, involuntary movements commonly of the face, lips and limbs.

Movement disorders were first described in people experiencing schizophrenia before the advent of first-generation antipsychotics, but the clear majority of these movement symptoms currently are induced by medicines. TD can be disabling and stressful and it had no FDA-approved treatment—until recently.

Earlier this year, the FDA approved a new medication for the treatment of TD with the trade name Ingrezza and generic name valbenazine. The FDA fast-tracked this medicine’s approval process, given TD’s unmet treatment need. The clinical trial that led to the approval evaluated the movements of 234 individuals with TD who were also diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder. These research subjects were randomly assigned valbenazine or a placebo (a sugar pill).  At six weeks, a clear difference emerged in the movement symptoms of the two groups, which led to the approval.

Another medication recently also received FDA-approval for the treatment of TD in adults. With the trade name Austedo and generic name deutetrabenazine, this medication was previously approved (in April 2017) for the treatment of chorea associated with Huntington’s disease. This second-indication approval was based on results from two randomized controlled group studies that found Austedo to be effective and safe in reducing the severity of abnormal involuntary movements associated with TD.

If you have TD, these medications are worth a fresh conversation with your prescriber. In study trials, these medicines appear to be well-tolerated, though as with most treatments, there are common and serious side effects (usually for people with heart rhythm issues).

The clinical focus for TD to date has been largely on prevention, which hasn’t very successful given its prevalence. Doctors assess TD symptoms with the Abnormal Involuntary Movement Scale (AIMS) scale. This should be performed on a regular basis (typically every 6 months). The AIMS exam is an assessment of a person for movements that could suggest TD; if TD is suspected, a discussion about lowering medication dosage or switching medication to one with less risk is typically advised.

TD can be avoided in some cases, but with long-term use of the medicine (tardy or emerging over time), the risks are increased. It’s hard to predict who will develop TD, but we do know that African-American, Asian-American, people with diabetes and individuals over 55 are at a greater risk. Many people take antipsychotics for decades, so the risk of developing TD is real and needs to be weighed against the benefits for symptom reduction and alternative treatments.

I have felt a bit helpless in the past when I see people who experience TD. We didn’t have any treatment options approved by the FDA. But now we have two new tools and I look forward to learning more about these medications from my patients’ experiences and scientific literature.

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